A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)



Status:Completed
Conditions:High Blood Pressure (Hypertension), Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - 89
Updated:3/30/2013
Start Date:July 2010
End Date:March 2013
Contact:For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email:Clinical.Trials@bms.com

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)


The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can
improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled
hypertension who are on an Angiotensin-converting enzyme (ACE) inhibitor or an Angiotensin
Receptor Blocker (ARB). The safety of this treatment will also be studied.


Inclusion Criteria:

- Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic
control HbA1c between 7-10.5% and uncontrolled hypertension Systolic Blood Pressure
(SBP) 140-165 and Diastolic Blood Pressure (DBP) 85-105

- Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks [12 wks for
Thiazolidinedione (TZD)] or a stable daily dose of insulin, as a monotherapy or in
combination with another OAD, for 8 weeks, and a stable dose of ACEI or ARB for at
least 4 weeks

- C-peptide ≥ 0.8 ng/mL

- Body Mass Index ≤ 45.0 kg/m2

- Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Exclusion Criteria:

- Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0 times
the upper limit of normal (ULN)

- Serum total bilirubin > 1.5 X ULN

- Creatinine kinase > 3 X ULN

- Symptoms of severely uncontrolled diabetes

- History of malignant or accelerated hypertension

- Currently unstable or serious cardiovascular, renal, hepatic, hematological,
oncological, endocrine, psychiatric, or rheumatic diseases
We found this trial at
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Bristol, Tennessee 37620
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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101 Riverstone Vista
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706-258-4112
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11524 N. Rodney Parham
Big Rock, Arkansas 72212
501-217-9170
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3590 West 9000 South West Jordan
Bingham, Utah 84088
801-542-8190
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3924 9th Avenue West
Bradenton, Florida 34205
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4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
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7440 North Shadeland Avenue
Lawrence, Indiana 46250
317-849-5749
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8200 SW 117th Ave # 210
Miami, Florida 33183
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1800 SW 1 ST #208
Miami, Florida 33135
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275 Alhambra Circle
Miami, Florida 33134
305-445-5637
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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1148 E. Commerce St.
San Antonio, Texas 78205
(210) 340-5646
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25200 Little Mack Ave.
St Clair Shores, Michigan 48081
586-552-8239
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3540 Duluth Park Lane
Suwanee-Duluth, Georgia 30096
387-387-3623
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
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Albuquerque, New Mexico 87108
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